Senior Manager, Clinical Product Supply Quality Assurance
Core
Strategic quality leadership and oversight for AbbVie's clinical development pipeline, ensuring timely delivery of compliant clinical supplies from drug substance through finished product.
Role type
Senior Manager, Clinical Product Supply Quality Assurance
Builds
Clinical development programs, investigational products, and third-party manufacturing partnerships
Domain
Pharmaceutical manufacturing, clinical supply chain, and regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic quality leadership, risk management, cross-functional influence, due diligence assessment, global GMP knowledge, issue management, investigation leadership, regulatory inspection readiness, quality agreement management, process improvement
Preferred skills
Master's degree in life sciences, Project Management Professional certification, M&A integration experience
Technologies
GMP, CMC, regulatory frameworks
Responsibilities
Provide strategic QA oversight for clinical development programs including risk management and executive communication; Serve as senior QA representative on CMC teams to enable investigational product progression; Establish risk-based quality positions for complex technical and compliance matters; Lead identification and mitigation of quality risks across the product lifecycle; Provide QA leadership for integration activities including in-licensing, collaborations, and third-party manufacturer onboarding; Lead quality assessments supporting due diligence and M&A activities; Collaborate to establish and maintain quality agreements with external partners; Lead cross-functional process improvement initiatives for clinical supply quality; Provide oversight for complex investigations, deviations, and product quality actions; Support regulatory inspection readiness and represent Quality during audits; Build alignment across R&D, Quality, and external stakeholders
Seniority
Senior Manager, strategic leadership with hands-on oversight
